Must a "Human Antibody" Be Entirely Human? Or May It Also Be "Partially Human?"

Attorney: Marina I. Miller, Ph.D.
October 16, 2020

This is a consolidated appeal from two Patent Trial and Appeal Board (“Board”) decisions in inter partes reviews (“IPRs”) of U.S. Patent 8,679,487 (“the ’487 patent”), owned by Immunex Corp. (“Immunex”). Sanofi-Aventis U.S. LLC, Genzyme Corp., and Regeneron Pharmaceuti-cals, Inc. (“Sanofi”) challenged the ’487 patent. The Board invalidated all challenged claims in IPR 2017-01884. Immunex appealed, contesting the construction of the claim term “human antibodies.” The Court of Appeals for the Federal Circuit (“the Court”) agreed with the Board’s claim construction and affirmed the invalidity decision.<... Read more

Indefiniteness: Bad Translation, Lack of Definition or Both?

Attorney: Daniel J. Pereira, Ph.D.
August 17, 2020

The Federal Circuit affirms the lower court ruling that “half-liquid” translated from the original Italian “semiliquido” is indefinite in IBSA Institut Biochimique, S.A., Altergon, S.A., IBSA Pharma Inc. v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. July 31, 2020). http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/19-2400.OPINION.7-31-2020_1628842.pdf<... Read more

The Federal Circuit Provides a Refresher on Joint Inventorship

Attorney: Daniel J. Pereira, Ph.D.
July 28, 2020

The decision in Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceuticals Co., Ltd, Tasuku Honjo, E.R. Squibb & Sons, L.L.C., Bristol-Myers Squibb Company (Fed. Cir., July 14, 2020) was an appeal of a determination of joint inventorship from the United States District Court for the District of Massachusetts.... Read more

Can One Have Too Many Patents?

Attorney: Richard D. Kelly
July 7, 2020

As is common with a blockbuster drug, AbbVie's Humira faced an antitrust challenge from third-party payers. The third-party payers filed an antitrust action claiming AbbVie's patent strategy stifled competition by forcing prospective competitors to settle on terms allowing Humira to enjoy a monopoly long after patent protection should have ended. The complaint alleges that AbbVie cornered the market for Humira and its biosimilars by obtaining a thicket of patents which allowed it to gain the market power it needed to prevent competitors from entering the U.S. market (violation of Sherman Act section 2). It used this market power to enter into settlement agreements with potential competitors to keep their products out of the U.S. market in return for early launch dates in Europe, also an important market which they termed a pay-for delay and market division (violation of Sherman Act section 1). Judge Shah, of the Northern District of Illinois, dismissed the complaint without prejudice on June 8, 2020. The opinion begins with a discussion of three reasons Humira might hold its commanding position foreshadowing his decision. First, the more than one hundred Humira-related patents made it difficult if not impossible to seek a non-infringing competing product.... Read more

FDA Seeking Comments on Orange Book Patent Listing

Attorney: Richard D. Kelly
June 29, 2020

The FDA has published a public notice requesting comments on the submission and listing of patent information. See the notice here. The information requested could lead to the implementation of changes having a significant impact on pharma, including combination products in the future, especially on combination products.<... Read more

Biogen v. Banner Life Sciences -- The Limited Scope Of U.S. Patent Term Extensions (Hint: Metabolites Not Included)

Attorney: Jeffrey B. McIntyre
May 12, 2020

Under 35 U.S.C. §156, a patentee can extend a patent’s term to restore part of the term consumed during the Food and Drug Administration’s (FDA) New Drug Application (NDA) approval process for a compound covered by the patent.<... Read more

CAFC Issues Another Precedential Decision on Standing

Attorney: Grace Kim
May 07, 2020

The Federal Circuit issued a precedential decision addressing standing requirements in Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., No. 2018-2273, slip op. (Fed. Cir. April 23, 2020).<... Read more

USPTO Decides an "Inventor" as a "Natural Person"

Attorney: Richard D. Kelly
April 28, 2020

The USPTO has published an apparently January 2020 Commissioner Decision effectively precluding the filing of patent applications where the invention was made solely by artificial Intelligence (AI). This decision has implications in the pharmaceutical industry where the use of AI to identify new compounds or uses for old compounds is utilizing AI. It also provides some guidance as to how the problem may be avoided.<... Read more

Obviousness of Compounds Having "Significant Structural and Functional Similarities" With Known Compounds

Attorney: Marina I. Miller, Ph.D.
April 27, 2020

Mylan Pharmaceuticals Inc. and others (“Mylan”) appealed from the District Court’s grant of summary judgment that claim 8 of U.S. Patent 8,552,025 owned by Valeant Pharm. Int’l, Inc.was not invalid. Valeant Pharm. Int’l, Inc. v. Mylan Pharm., Inc., No. 2:15-cv-08180 (SRC), 2018 WL 2023537 (D.N.J. May 1, 2018). The Court of Appeals for the Federal Circuit (“the Court”) reversed the decision of the district court.<... Read more

Patent Eligible Method of Treatment/Prevention Claim

Attorney: Yuki Onoe
March 23, 2020

特許適格性を満たす治療/予防方法クレーム の例<... Read more